Type:

full-time

Job Description:

Job title: Sr Manufacturing Engineer Work location : Marlborough, MA This initiative supports a large-scale remediation effort across multiple sites, focused on strengthening manufacturing and quality systems for Class

II/III IVD

products. The team will be responsible for identifying and closing gaps in existing processes, validation documentation, and risk management frameworks across both high-volume and complex manufacturing environments. Resources will work cross-functionally to execute validations, drive CAPAs, update documentation, and improve overall process control and yield. This is a hands-on, floor-facing effort requiring senior- level contributors who can independently assess issues, execute solutions, and communicate effectively from operators through leadership. This is a Hands-on manufacturing engineering role for Class

II/III IVD

products in a high-volume production environment, with heavy involvement in remediation-driven improvements. Key Responsibilities Support day-to-day manufacturing operations directly on the floor Partner closely with operators to troubleshoot process issues and improve yield consistency Lead and execute validation activities (IQ/OQ/PQ) tied to remediation efforts Drive CAPAs and failure investigations through root cause to implementation Identify and escalate manufacturing risks and process gaps Support and implement drawing updates and engineering changes Execute change control activities (SOP updates, process changes, documentation) Facilitate cross-functional discussions across Quality, Validation, and Operations Mentor floor personnel and junior engineers on best practices and standards Required Experience Strong experience with OQs 10-15+ years in manufacturing engineering within medical devices (Class

II/III IVD

preferred) Strong experience with: Process validation in production environments PFMEA development and risk-based decision making CAPA and nonconformance investigations Change control systems experience Proven ability to operate independently and get up to speed quickly in active manufacturing environments Comfortable working directly on the production floor and engaging operators through leadership Strong communication skills across all levels (operators leadership)","accountId","46137886","Fusion Life Sciences Technologies LLC","https://www.disabledperson.com/jobs/74623999-sr-manufacturing-engineer","location",{"_464":465,"_466":467},"createdAt","2026-08-30T19:58:42.732630320Z","status","active","isDiscoverable","isSearchable","isSpotlight","isDraft","careerSkills",[404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422],"requiredEducation","na","isEmailRequired","isPhoneRequired","titleSearch","Manufacturing 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